Ligence Heart— 510(k) K253535

Substantially Equivalent

Ligence Uab

FDA 510(k) clearance K253535 for Ligence Heart, Substantially Equivalent on 2026-02-27. Applicant: Ligence Uab.

Clearance details

Applicant: Ligence Uab
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-11-13
Decision date: 2026-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaunas, LT

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